Status:
WITHDRAWN
Intervention of Engineered Immune Effector T Cells Against Lung Cancer
Lead Sponsor:
Shenzhen Geno-Immune Medical Institute
Conditions:
Lung Cancer
NSCLC
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
PHASE2
Brief Summary
The primary objective of this study is to evaluate the safety of lung cancer specific cytotoxic lymphocytes (LC-CTLs). The secondary objectives are to evaluate the rate of successful LC-CTLs generatio...
Detailed Description
Lung cancer is a malignant lung tumor characterized by uncontrolled cell growth in tissues of the lung. The two main types are small-cell lung carcinoma (SCLC) and non-small-cell lung carcinoma (NSCLC...
Eligibility Criteria
Inclusion
- Written, informed consent obtained prior to any study-specific procedures.
- Age older than 18 years.
- Patients with refractory, relapsed, metastatic, advanced lung cancer confirmed by histology and biopsy.
- Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1.
- Expected survival ≥ 12 weeks.
- Not pregnant, and on appropriate birth control if of childbearing potential.
- Initial hematopoietic reconstitution with
- neutrophils (ANC) ≥ 1,000/mm\^3;
- platelet (PLT) ≥ 100,000/mm\^3.
- Proper renal and hepatic functions (ULN denotes "upper limit of normal range") with
- serum creatinine ≤ 2×ULN;
- serum bilirubin ≤ 2×ULN;
- AST/ALT ≤ 2×ULN;
- ALKP ≤ 5×ULN;
- serum bilirubin. 2.0 is acceptable in the setting of known Gilbert's syndrome.
- Human immunodeficiency virus (HIV) and Hepatitis C virus (HCV) test were negative.
Exclusion
- Have occurred in 5 years or are currently suffering from other cancers, except for cured cervical cancer, non-melanoma skin cancer and superficial bladder cancer.
- Previous exposure to mouse CEA antibody.
- Current or recent treatment (within the 28-day period prior to Day 0) with another investigational drug or previous participation in this study.
- Minor surgical procedures within 2 days prior to Day 0 (including central venous access device placement for chemotherapy administration, tumor biopsies, needle aspirations).
- Pregnant or lactating females.
- Inadequate bone marrow function with
- absolute neutrophil count \< 1,000/mm\^3;
- platelet count \< 100,000/mm\^3;
- Hb \< 9 g/dL.
- Inadequate liver and renal function with
- serum (total) bilirubin \> 1.5 x ULN;
- AST \& ALT \> 2.5 x ULN (\> 5 x ULN in patients with liver metastases);
- alkaline phosphatase \> 2.5 x ULN;
- serum creatinine \>2.0 mg/dl (\> 177 μmol/L);
- urine dipstick for protein uria should be \< 2+. Patients with ≥ 2+ proteinuria on dipstick urinalysis at baseline should undergo 24 hour urine collection and must demonstrate \< 1 g of protein/24 hr.
- Serious active infection requiring i.v. antibiotics at during screening.
- Subject infected with HCV (HCV antibody positive), HBV (HBsAg positive), HIV (HIV antibody positive), HTLV (HTLV antibody positive), Treponema pallidum antibody positive or TB culture positive.
Key Trial Info
Start Date :
November 15 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03353428
Start Date
November 15 2017
End Date
December 1 2020
Last Update
March 27 2018
Active Locations (1)
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1
Shenzhen Geno-immune Medical Institute
Shenzhen, Guangdong, China, 518000